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FDA 510(k)

AlignRT Plus (8.0)

K-Number: K253012 · 2026-03-18

ApplicantVision Rt, Ltd.
Decision Date2026-03-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AlignRT Plus (8.0) is the device name listed in this FDA 510(k) record. The listed applicant is Vision Rt, Ltd.. It received FDA 510(k) clearance on 2026-03-18 under 510(k) number K253012. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlignRT Plus (8.0)?

AlignRT Plus (8.0) is a medical device that received FDA 510(k) clearance on 2026-03-18. The listed applicant is Vision Rt, Ltd.. The 510(k) number is K253012.

When did AlignRT Plus (8.0) receive FDA 510(k) clearance?

AlignRT Plus (8.0) received FDA 510(k) clearance on 2026-03-18, under 510(k) number K253012.

Who is the listed applicant for AlignRT Plus (8.0)?

The FDA 510(k) record lists Vision Rt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AlignRT Plus (8.0)?

The FDA product code for AlignRT Plus (8.0) is IYE.

Other records listing Vision Rt, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243301MapRTK233622AlignRT PlusK231185MapRTK212583AlignRT PlusK203387AlignRT PlusK193431AlignRT Plus

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Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser ApplikationenK260792AerFrame Patient Immobilization System (AFPIS)Stabilix, LLCK252258VERIQA RT EPID 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. PychlaK253962ClearCheck (RADCC V2.7)Radformation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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